Trial results for a study investigating musical engagement in Alzheimer's Disease patients were posted on ClinicalTrials.gov on 2025-09-09, with 10 participants enrolled.
Background
Alzheimer's Disease is a progressive neurodegenerative disorder that primarily affects memory, thinking, and behavior, significantly impacting the quality of life for patients and their caregivers. As the disease advances, individuals may experience increased agitation, anxiety, and cognitive decline, often leading to challenges in communication and engagement. Non-pharmacological interventions, such as music therapy, are being explored for their potential to manage behavioral symptoms and enhance emotional well-being in patients with moderate to severe Alzheimer's disease. This study aimed to assess the global and clinical impact, as well as the level of arousal, in subjects exposed to emotionally impactful music compared to a control intervention.
Trial design
This completed randomized, cross-over study, designated as Phase NA, enrolled 10 participants with conditions including Alzheimer Disease, Dementia, and exploring Music Therapy. The trial compared the effects of emotionally impactful music against a control intervention of nature sounds. The study's objective was to measure the global and clinical impact and level of arousal, with key measurements focusing on changes in intervention response as evaluated by the Clinical Global Impression of Change (CGIC).
Key results
The trial reported changes in intervention response as evaluated by the Clinical Global Impression of Change (CGIC) for both intervention arms. The data presents participant counts across various, unspecified categories of CGIC response:
- For the Preferred Music group:
- 0 participants
- 5 participants
- 2 participants
- 1 participant
- 1 participant
- 1 participant
- For the Nature Sounds group:
- 0 participants
- 2 participants
- 0 participants
- 4 participants
- 1 participant
- 3 participants
What this means
The posted results provide preliminary data on the Clinical Global Impression of Change (CGIC) for 10 participants with moderate to severe Alzheimer's disease exposed to either preferred music or nature sounds. While the specific categories of CGIC response are not detailed, the counts indicate how participants were distributed across different levels of change. This initial data contributes to understanding the potential impact of musical engagement and environmental sounds on clinical impression in this patient population, informing future research directions for non-pharmacological interventions in Alzheimer's care.
Source
The information regarding these trial results was obtained from ClinicalTrials.gov, a public database of clinical studies. The results for the study NCT05309369, titled "Musical Engagement of Brain LObes in Alzheimer's Disease Patients StudY", were posted on 2025-09-09 on clinicaltrials.gov.